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Laser Versus Vitrectomy Versus Intravitreal Triamcinolone Injection for Diabetic Macular Edema (VITRILASE)

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ClinicalTrials.gov Identifier: NCT00764244
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
Macular edema is the main cause of vision loss in diabetic patients. Its treatment is mainly based on laser photocoagulation, but has limited results. Alternative treatment are under investigation, such as vitrectomy and intravitreal injections of triamcinolone .The aim of VITRILASE is to compare the efficacy of these two treatments to laser photocoagulation for diabetic macular edema.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Diabetes Procedure: Vitrectomy Drug: Intravitreal triamcinolone injections Procedure: Laser photocoagulation Phase 3

Detailed Description:

It is a randomized study with three arms

  • vitrectomy
  • repeat intravitreal triamcinolone injections
  • laser photocoagulation
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VITRILASE Study: Prospective Randomized Trial Comparing the Effect of Laser, Vitrectomy and Intravitreal Triamcinolone Injection for Diabetic Macular Edema
Study Start Date : January 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Vitrectomy
 Procedure: Vitrectomy
Vitrectomy
Active Comparator: 2
Intravitreal triamcinolone injections
 Drug: Intravitreal triamcinolone injections
Intravitreal triamcinolone injections
Other Names:
  • - KENACORT RETARD
  • - Triamcinolone Acetonid
Active Comparator: 3
Laser photocoagulation
 Procedure: Laser photocoagulation
Laser photocoagulation


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients with visual gain ≥ 3 ETDRS lines at 2 years [ Time Frame: at 2 years ]

Secondary Outcome Measures :
  1. Central macular thickness on Optical Coherence Tomography (OCT) [ Time Frame: at 8, 12 and 24 months ]
  2. Percentage of patients with visual gain ≥ 3 ETDRS lines [ Time Frame: 8, 12 and 22 months ]
  3. Progression of lens opacities [ Time Frame: During the all follow-up ]
  4. Frequency of complications [ Time Frame: During the all follow-up ]
  5. Results analysis according to preoperative vitreous detachment, honeycomb macular edema on fluorescein angiography [ Time Frame: at inclusion time ]
  6. Evolution of visual fiends and posterior vitreous detachment [ Time Frame: At inclusion time and 2 years ]
  7. Percentage of patients presenting an increase of 2 line or more of best corrected visual acuity on ETDRS charts [ Time Frame: after 1 year, 22 months and 24 months of follow-up ]
  8. Percentage of patients presenting an decrease of 2 line or more of best corrected visual acuity on ETDRS charts [ Time Frame: after 1 year, 22 months and 24 months of follow-up ]
  9. Scores ETDRS [ Time Frame: after 1 year, 22 months and 24 months of follow-up ]
  10. Mean best corrected visual acuity during follow-up period [ Time Frame: during the all follow-up ]
  11. Progression of retinopathy diabetic in each group [ Time Frame: during the all follow-up ]
  12. Outcome in respect to posterior vitreal detachment (PVD) stage [ Time Frame: during the all follow-up ]
  13. PVD stage evolution during the follow-yp in laser and triamcinolone group [ Time Frame: first and last exam ]
  14. Evolution of visual field in each group [ Time Frame: inclusion and last visit ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient with type 1 or type 2 diabetes
  2. Visual acuity (VA) : 0.1≤ VA < 0.5 (35 ≤ ETDRS score < 70)
  3. Patient with diffuse diabetic macular edema , as defined by :§ Retinal thickening involving the center of the macular on biomicroscopy§ AND diffuse leakage on fluorescein angiography .
  4. Macular thickness in the central area 1000 µm in diameter ³ 300 µm.
  5. Patient with :· Either diffuse diabetic macular edema · Or combined diffuse and focal diabetic macular edema with persistent diffuse macular edema 6 months after laser treatment of the focal edema .
  6. Systolic blood pressure ≤ 160 mmHg and diastolic blood pressure ≤ 90 mmHg.,
  7. HbA1c < 10%.

Exclusion Criteria:

  1. Patient with tractional diabetic macular edema, as defined by· A taut, thickened posterior hyaloid on biomicroscopy AND/OR· a thickened , highly reflective posterior hyaloid on OCT , partially detached from the posterior pole, and exerting a traction on the macula
  2. Active proliferative diabetic retinopathy (ETDRS stage 61 or more severe)
  3. Structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), or organized central hard exudate plaque³ 1 disk area
  4. Hypertensive retinopathy
  5. Epiretinal membrane.
  6. Rubeosis irides .
  7. Patient requiring immediate panretinal photocoagulation or panretinal photocoagulation performed within the past 6 months .
  8. History of chronic glaucoma in the study eye
  9. History of elevated intraocular pressure ≥30 mm Hg and/or alteration of visual field
  10. Concomitant therapy with systemic or topical ocular corticosteroids within the last 15 days .
  11. Cataract surgery in the study eye within the past 6 months, Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within the past 6 months,
  12. Aphakia
  13. Patient with pseudophakic macula edema
  14. Unstable medical status including glycemic control and blood pressure. Patients in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) should not be enrolled.
  15. Chronic renal failure
  16. Pregnant or nursing (lactating) women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764244


Locations
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France
Pascale MASSIN
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Pascale MASSIN, MD, PhD; Pr Assistance Publique - Hôpitaux de Paris
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00764244    
Other Study ID Numbers: P030426
MUL03010
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: November 2014
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Diabetes
Macular edema
Optical Coherence tomography
VitrectomyLaser therapy
Intravitreal triamcinolone injection
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
 Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action